Clinical Trial Shows Diabetes Drug May Help Treat Liver Inflammation

A new study found that dapagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, improved key liver conditions associated with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis, according to a new clinical trial published in The BMJ.

MASH is a form of non-alcoholic fatty liver disease (NAFLD) characterized by the accumulation of fat in the liver, leading to inflammation and, in many cases, scarring or fibrosis. It is considered a major global health concern, with few effective pharmacological treatments currently available.

To evaluate the impact of dapagliflozin on MASH, researchers enrolled 154 adults across six medical centers in China between November 2018 and March 2023. Participants had all been diagnosed with MASH following a liver biopsy. Nearly half had type 2 diabetes, and almost all had evidence of liver fibrosis.

Patients were randomly assigned to receive either 10 mg of dapagliflozin or a placebo once daily for 48 weeks. They also attended biannual health education sessions and underwent regular assessments of liver enzymes, blood glucose, insulin, lipid profiles, and other metabolic markers.

At the end of the trial, a second liver biopsy showed that 53% of those receiving dapagliflozin experienced improvement in MASH without worsening of fibrosis, compared with 30% in the placebo group. Additionally, resolution of MASH without fibrosis worsening was observed in 23% of the dapagliflozin group, versus 8% in the placebo group. Improvement in fibrosis without worsening MASH was reported in 45% of the dapagliflozin group, compared to 20% of those given the placebo.

The researchers noted the trial’s limitations, including its focus on a predominantly male, Chinese population, and the need for broader and longer-term studies. Still, they concluded: “Our findings indicate that dapagliflozin may affect key aspects of MASH by improving both steatohepatitis and fibrosis.”

An accompanying editorial highlights the growing momentum in developing pharmacological treatments for MASH, emphasizing the future importance of individualized treatment strategies that also address cardiovascular health and safety.

Reference: Lin J, Huang Y, Xu B, Gu X, Huang J, Sun J et al. Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial BMJ 2025; 389 :e083735 doi:10.1136/bmj-2024-083735